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The purpose of this study is to determine whether RNS60 is effective in the treatment of RR-MS compared to interferon beta-1a.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RNS60 125 ml | Experimental | 125 ml of RNS60 administered weekly by IV infusion |
|
| RNS60 250 ml | Experimental | 250 ml of RNS60 administered weekly by IV infusion |
|
| Interferon beta-1a | Active Comparator | Weekly dose of 30 mcg Interferon beta-1a (Avonex) administered by intramuscular injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RNS60 125 ml | Drug |
| ||
| RNS60 250 ml |
| Measure | Description | Time Frame |
|---|---|---|
| Change in number of GAD-enhancing lesions from baseline | Cumulative number of GAD-enhancing lesions by MRI at months 3, 4, 5, and 6 | 3, 4, 5, and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in number of T2 lesions from baseline | Cumulative number of new or newly enlarged T2 lesions over 6 months of treatment | Months 3, 4, 5, and 6 |
| Brain volume | Brain volume by MRI over 6 months of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fred Lublin, MD, PhD | Mt. Sinai School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mt. Sinai School of Medicine | New York | New York | 10029 | United States |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000627108 | RNS60 |
| D000068556 | Interferon beta-1a |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
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|
| Interferon beta 1a | Drug |
|
| 6 months |
| T2 lesion volume | T2 lesion volume by MRI over 6 months of treatment | 6 month |
| Annualized Relapse Rate | Annualized Relapse Rate over 6 months | 6 months |
| Expanded Disability Status Scale (EDSS), change from baseline | Progression of disability as assessed by the Expanded Disability Status Scale at months 3 and 6. | 3, 6 months |
| Multiple Sclerosis Functional Composite, change from baseline | Progression of disability as assessed by the Multiple Sclerosis Functional Composite tool at months 3 and 6 months. | 3, 6 months |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D036341 |
| Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |